Not Applicable.
1. The Field of the Invention
The present invention relates generally to orthopedic bone fixation devices for stabilizing a plurality of bone segments, and more particularly, but not necessarily entirely, to a bone plate and a bone screw assembly for stabilizing the cervical spine and blocking movement of grafts, and otherwise maintaining the cervical vertebrae in a desired relationship.
2. Description of Related Art
The spine is a flexible, multi-segmented column that supports the upright posture in a human while providing mobility to the axial skeleton. The spine serves the functions of encasing and protecting vital neural elements and provides structural support for the body by transmitting the weight of the body through the pelvis to the lower extremities. Because there are no ribs attached to either the cervical spine or the lumbar spine, they have a relatively wide range of motion.
The spine is made up of bone, intervertebral discs, synovial joints with their articular cartilage, synovial capsules and, as part of the back, is surrounded by supporting ligaments, muscle, fascia, blood vessels, nerves, and skin. As in other areas of the body, these elements are subject to a variety of pathological disturbances: inflammation, trauma, neoplasm, congenital anomalies, disease, etc. In fulfilling its role in the back, the spine can be subjected to significant trauma which plays a dominant role in the etiology of neck and low back pain. Trauma frequently results in damage at the upper end of the lumbar spine, where the mobile lumbar segments join the less mobile dorsal spine. Excessive forces on the spine not only produce life-threatening traumatic injuries, but may contribute to an increased rate of degenerative change.
The cervical spine comprises the first seven vertebrae of the spine, which begin at the base of the skull and end at the upper torso. Because the neck has a wide range of motion and is the main support for the head, the neck is extremely vulnerable to injury and degeneration.
Spinal fixation has become a common approach in treating spinal disorders, fractures, and for fusion of the vertebrae. One common device used for spinal fixation is the bone fixation plate. Generally, there are two types of spinal plates available, (i) constrained plates and (ii) semiconstrained plates. Generally, a constrained plate completely immobilizes the vertebrae and does not allow for graft settling. In contrast, a semiconstrained plate is dynamic and allows for a limited degree of graft settling through micro-adjustments made between the plate and bone screws attaching the plate to the spine perhaps by way of an intervening coupling ring that holds the screws within the plate. The operation of the semiconstrained plate stimulates bone growth. Each type of plate has its own advantages depending upon the anatomy and age of the patient, and the results desired by the surgeon.
A typical bone fixation plate includes a relatively flat, rectangular plate having a plurality of holes formed therein. A corresponding plurality of bone screws may be provided to secure the bone fixation plate to the vertebrae of the spine.
A common problem associated with the use of bone fixation plates is the tendency for bone screws to become dislodged and xe2x80x9cback outxe2x80x9d from the bone, thereby causing the plate to loosen. Some attempts to provide a screw with polyaxial capabilities to help avoid screw xe2x80x9cback outxe2x80x9d are known throughout the prior art. However, many of these attempts have resulted in a bone fixation plate having a very large profile size that can cause irritation and discomfort in the patient""s spinal region, or an assembly with multiple parts that must be assembled prior to implantation, which can be laborious and time consuming for surgeons.
In a typical anterior cervical fusion surgery, the carotid sheath and sternocleidomastoid muscles are moved laterally and the trachea and esophagus are moved medially in order to expose the cervical spine. The cervical plate is designed to lie near and posterior to the esophagus. Due to its relative location to the esophagus and other connective tissue, if the bone screw securing the plate to the cervical spine backs out, the bone screw could pierce the esophagus, causing not only pain and infection, but also posing a serious risk of death to the patient. The anti-back out mechanism is important not only to avoid piercing of the esophagus, but also to reduce the profile size of the plate, such that no post-operative difficulty in swallowing is experienced by the patient.
There are several spinal fixation devices known in the prior art. U.S. Pat. No. 6,193,720 (granted Feb. 27, 2001 to Yuan et al.) discloses a cervical spine stabilization device. This cervical spine fixation device requires multiple component parts to provide fixation between a plurality of vertebrae. This device is complex in operation because it requires multiple parts, each of which must be adjusted by the surgeon during surgery, causing extra unnecessary and unwanted labor and time.
U.S. Pat. No. 6,022,350 (granted Feb. 8, 2000 to Ganem) discloses a bone fixation device comprising an elongate link for receiving at least one bone-fastening screw containing a semi-spherical head, which bone-fastening screw passes through an orifice created in the elongate link. The bottom of the elongate link contains a bearing surface that essentially has a circular cross section, allowing the semispherical head to be seated therein. The device further includes a plug having a thread suitable for coming into clamping contact against the screw head to hold the head in a desired angular position. This device is characterized by several disadvantages, including the need for a larger profile fixation device in order to allow the semi-spherical bone-fastening screw head and the accompanying plug to fit within the bearing surface. Ganem""s larger profile design reduces the effectiveness of the device because of the potential for increased discomfort for the patient.
It is noteworthy that none of the prior art known to applicants provides a spinal fixation device having a low profile size, utilizes few component parts, and provides the surgeon with the ability to manipulate and micro-adjust the fixation device. There is a long felt, but unmet, need for a spinal fixation device which is relatively inexpensive to make, simple in operation and provides a secure interlock between the head of a fastener, such as a bone screw, and the inner sidewall of a receiving member, which is located within a plate hole, that also has a low profile.
The prior art is thus characterized by several disadvantages that are addressed by the present invention. The present invention minimizes, and in some aspects eliminates, the above-mentioned failures, and other problems, by utilizing the methods and structural features described herein.
The features and advantages of the invention will be set forth in the description which follows, and in part will be apparent from the description, or may be learned by the practice of the invention without undue experimentation. The features and advantages of the invention may be realized and obtained by means of the instruments and combinations particularly pointed out in the drawings, subsequent detailed description and appended claims.